MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number M00560321

Device Problems Entrapment of Device (1212); Defective Device (2588)

Patient Problem Hematoma (1884)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.  if any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a sensation small oval med stiff snare was used during an unknown procedure on (b)(6) 2018.According to the complainant, during the procedure, when the snare was slowly extended, the snare came flying out and went all the way through underneath the mucosa/polyp and created a hematoma.The snare "burrowed" all the way underneath the polyp/mucosa.Reportedly, the snare came out suddenly/unexpectedly and too far and fast and was embedded in the patient's tissue.It was unknown if any treatment or intervention was done to treat the hematoma.The procedure was completed using a different device.The condition of the patient following the procedure was reported to be unknown.Should additional relevant details become available a supplemental report will be submitted.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8248722
• MDR Text Key: 133089569
• Report Number: 3005099803-2019-00047
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: 08714729283928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1